510(k) K122382
- Device
- DYNASTY BIOFOAM SHELL
- Applicant
- WRIGHT MEDICAL TECHNOLOGY, INC.
- 510(k) number
- K122382
- Product code
- MBL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-10-22
- Date received
- 2012-08-06
- Regulation
- 888.3358
- Classification name
- Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEAN NACHTRAB
- Address
- 5677 Airline Rd. Arlington TN US 38002 38002
FDA Registration Numbers#
- 2245304
- 3009173317
- 3016438694
- 3030412764
- 3003761012
- 3003541440
- 3011295718
- 3003477135
- 1020279
- 3009888740
- 3005551626
- 1226544
- 3009959868
- 8044172
- 3011274144
- 3010123256
- 3010220595
- 3017397663
- 3009973336
- 3027484613
- 3036773273
- 3014302784
- 1722511
- 2183744
- 2249615
- 1529009
- 8043792
- 3004142400
- 9614209
- 3012725451
- 1450662
- 9613369
- 3021008900
- 3013176080
- 3002807310
- 3022142628
- 3002907620
- 1057425
- 1018470
- 3043543260
- 1043653
- 3026771806
- 9611390
- 1720929
- 3007913880
- 3003387384
- 1644408
- 3009546990
- 3013014058
- 3033509898
- 3002806603
- 1828464
- 3011277306
- 3008744062
- 1038671
- 3008281151
- 3008572101
- 3014763043
- 3008544874
- 3008556682
- 1825034
- 1649518
- 3002807314
- 9681465
- 3009813841
- 1835251
- 3004188066
- 1835444
- 3023852420
- 3001278222
- 3010120135
- 3035366890
- 3008021110
- 1643264
- 3010041693
- 3016778562
- 3009998573
- 3009882462
- 3007366790
Source Documents#
Other 510(k) Records For Product Code MBL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201157 | Prime BIOFOAM® Multi-Hole Shells | Microport Orthopedics, Inc. | 2021-08-24 |
| K201701 | R3 HA Coated Acetabular Shells | Smith & Nephew, Inc. | 2020-10-06 |
| K182535 | R3 Anteverted Liners | Smith & Nephew, Inc. | 2018-11-19 |
| K161233 | OXINIUM DH Fermoral Heads | Smith & Nephew, Inc. | 2016-12-14 |
| K113848 | R3 XLPE LINERS | Smith & Nephew, Inc. | 2012-04-27 |
| K102370 | R3 XLPE ANTEVERTED LINERS | Smith & Nephew, Inc. | 2011-01-19 |
| K093363 | COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS | Smith & Nephew, Inc. | 2010-01-26 |
| K092386 | R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS | Smith & Nephew, Inc. | 2009-11-03 |
| K070756 | SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM | Smith & Nephew, Inc. | 2007-06-06 |
| K061253 | REFLECTION 3 ACETABULAR SYSTEM | Smith & Nephew, Inc. | 2006-05-31 |
| K960094 | REFLECTION DUAL DIMENSION SHELL | Smith & Nephew Richards, Inc. | 1996-03-27 |
| K931107 | LOGYK ACETABULAR COMPONENT SYSTEM | Arthronics, Inc. | 1994-03-28 |
Legacy Summary#
summary
FDA Review#
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